MediPines Corporation
| ISIN | 🆔 |
|---|---|
| Industry | Medical devices |
| Founded 📆 | 2015 |
| Founder 👔 | |
| Headquarters 🏙️ | Orange County, California, USA |
Area served 🗺️ | |
| Products 📟 | MediPines AGM100 |
| Members | |
Number of employees | |
| 🌐 Website | www |
| 📇 Address | |
| 📞 telephone | |
MediPines is a medical device company based in Orange County, California. It is the manufacturer of the MediPines AGM100, the first commercially available noninvasive pulmonary gas exchange analyzer which provides a comprehensive set of medical-grade respiratory parameter measurements using a breath-based sampling method..[1]
History[edit]
MediPines was launched in 2015 with its first product being the MediPines AGM100, a medical device which measures oxygen and carbon dioxide partial pressures of the lung to determine respiratory gas exchange efficiency. The underlying technology was developed by the founder Steve Lee, a medical systems engineer, and John B. West, a noted respiratory physiologist at the UC San Diego School of Medicine.
MediPines products are currently in use at hospitals in the US and Canada[2] to conduct respiratory assessments, support therapies, and confirm treatment effectiveness.[3] Their gas exchange analyzer system has received FDA 510(k) clearance for respiratory gas exchange monitoring.[4] In 2020, MediPines received approval from Health Canada for COVID-19 Emergency Use.[5] The company was listed as a top 10 patient monitoring solution provider in 2020 according to MD Tech Review's annual ranking[6], and was featured by MD&DI[7] amongst other finalists in the MDE Awards 2021[8]. In August 2021, the AGM100 was listed in the WHO Compendium of innovative health technologies for low-resource settings[9]
Technology and uses[edit]
Gas Exchange Analyzer System (AGM100)[edit]
The AGM100 is a multi-parameter respiratory monitoring device which measures respiratory oxygen (PO2, PAO2) and carbon dioxide (PETCO2) levels, respiratory rate, arterial oxygen saturation (SpO2), pulse rate, and calculates arterial PaO2 and oxygen deficit (PAO2-PaO2). Patient measurements are obtained at rest in a two-minute measurement session using a breathing circuit. The AGM100 is the first medical device to noninvasively determine values of arterial oxygenation.[10] The detection of pulmonary dysfunction due to gas exchange impairments is benefecial to the medical diagnosis and treatment of chronic and acute respiratory diseases such as chronic obstructive pulmonary disease, pulmonary embolism, acute respiratory distress syndrome and recently COVID-19.[5][11] This gas exchange analyzer is in use as a rapid, accurate, and painless method to obtain patient respiratory gas measurements which are traditionally offered through the arterial blood gas test, an invasive blood sampling method and the current gold standard. The noninvasive method has demonstrated a precision similar to that of the arterial blood gas test with a high degree of correlation.[12] Rapidly determining the degree of respiratory impairment has been a medical challenge for years as respiratory patients commonly require immediate medical attention. Precise measurement of the degree of respiratory impairment is important because it allows clinicians to vary therapies, titrate the level of treatment, and make better-informed triage and discharge decisions.
Respiratory Physiology[edit]
The lungs participate in respiration by exchanging gas between the environment and blood. Fresh oxygen (O2) is brought in during inhalation and stale carbon dioxide (CO2) is brought out during exhalation. This process occurs deep within the lungs in an area known as the blood-air barrier. Here, small air sacs called alveoli allow for the diffusion of oxygen and carbon dioxide to and from the blood. This diffusion process, called pulmonary gas exchange, is made possible due to a difference in the partial pressure of the gas. Human lungs contain several hundred million alveoli which are dedicated to this process of gas exchange. In a clinical setting, however, patients with respiratory diseases such as COPD experience inefficient pulmonary gas exchange due to structural damage within their lungs. This results in abnormal blood-gas measurements (PO2, PCO2 typically measured in mmHg), and difficulty breathing. Furthermore, PO2 and PCO2 levels change as they cascade downward and upward, respectively, through the respiratory tract. In clinical practice, gas-based indices are compared at different points in the body to source the origin of various causes of gas exchange impairment. The values of oxygen and carbon dioxide in healthy lung tissue, specifically in the alveoli, will be close to that of blood in the arteries. Gas levels are named according to the phase of the respiratory cycle and the site of measurement. For example, “alveolar” gas values are referred to as “end-tidal” values and refer to the amount of gas left in the lungs at the end of normal exhalation.
Oxygen Deficit[edit]
The alveolar-arterial gradient, also known as oxygen deficit, is the difference between end-tidal O2 in lungs (PAO2) and a calculated partial pressure of arterial oxygen (gPaO2). This is the degree of inefficiency of the lung to transfer oxygen into capillary blood. The oxygen deficit is calculated as O2Deficit = PETO2(PAO2) – gPaO2 and is expressed in mmHg.[13] Patients typically have single digit to zero values; respiratory patients have a larger gap (e.g., 30 to 50 mmHg or higher). In patients with worsening gas exchange, oxygen deficit typically changes more than oxygen saturation, making it a more sensitive indicator of gas exchange impairment. This wider margin increases the ability of medical professionals to recognize and respond to deteriorating conditions.
Clinical Publications[edit]
The following studies were conducted and published in support of oxygen deficit and the AGM100:
- Go West: Translational Physiology for Noninvasive Measurement of Pulmonary Gas Exchange in Patients with Hypoxemic Lung Disease. Pickerodt P.A., & Kuebler W.M. American Journal of Physiology, Lung Cellular and Molecular Physiology. 2019 Mar 6;316: L701–L702.[14]
- A New, Noninvasive Method of Measuring Impaired Pulmonary Gas Exchange in Lung Disease: An Outpatient Study. West J.B., Crouch D.R., Fine J.M., Makadia D., Wang D.L., Prisk G.K. CHEST. 2018;154(2), pp. 363-369.[15]
- Measurements of pulmonary gas exchange efficiency using expired gas and oximetry: results in normal subjects. West, J.B., Wang, D.L., Prisk D.K. American Journal of Physiology. Lung Cellular Molecular Physiology. 2018 Apr 1;314(4): L686-L689.[16]
- Noninvasive measurement of pulmonary gas exchange: comparison with data from arterial blood gases. West, J. B., Wang, D. L., Prisk, G. K., Fine, J. M., Bellinghausen, A., Light, M. P., & Crouch, D. R. American Journal of Physiology. Lung Cellular and Molecular Physiology. 2018.[12]
- A lifetime of pulmonary gas exchange. West, J.B. Physiological Reports. 2018 Oct;6(20):e13903.[17]
- Measuring the efficiency of pulmonary gas exchange using expired gas instead of arterial blood: comparing the “ideal” Po2 of Riley with end-tidal Po2. West JB, Liu MA, Stark PC, Prisk GK. American Journal of Physiology. Lung Cellular and Molecular Physiology 2020;319(2):L289-L293.[18]
- Validation of a Non-invasive Assessment of Pulmonary Gas Exchange During Exercise in Hypoxia. Ainslie, Philip N., Howe, Connor A., MacLeod, David B., Wainman, Liisa, Oliver, Samuel J., CHEST. 2020 Apr.[13]
Further Reading[edit]
- Post-operative pulmonary complications after non-cardiothoracic surgery. Kelkar K.V. Indian Journal of Anaesthesia. 2015 Sep; 59(9): 599–605.[19]
- Do pulmonary function tests improve risk stratification before cardiothoracic surgery? Ivanov, A., Yossef, J., Talion, J., Worku, B.M., Gulkarov, I., Tortolani, A.J., Sacchi, T.J., Briggs, W.M., Brener, S.J., Weingarten, J.A., & Hietner, J.F. The Journal of Thoracic and Cardiovascular Surgery. Apr 2016; 151(4), 1183-1189.e3.[20]
- Postoperative pulmonary complications. Miskovic, A., & Lumb, A.B. BJA: British Journal of Anaesthesia. Mar 2017; 118(3) 317-334.[21]
- Identifying Patients With COPD at High Risk of Readmission. Simmering, J.E., Polgreen, L.A., Comellas, A.P., Cavanaugh, J.E., & Polgreen, P.M. Chronic Obstr Pulm Dis. 2016; 3(4): 729-738. [22]
See also[edit]
References[edit]
- ↑ "MediPines Corporation Achieves ISO 13485 Certification". Medical Product Outsourcing.
- ↑ Klein, Roger (9 December 2020). "Stevenson Memorial uses game-changing device with COVID-19 patients". CTV News Barrie.
- ↑ "Coronavirus company news summary". Medical Device Network.
- ↑ "Establishment Registration & Device Listing". www.accessdata.fda.gov.
- ↑ 5.0 5.1 "Portable, Non-Invasive Respiratory Monitoring System Helps Detect Presence of COVID-19 in At-Risk Elderly Population". Hospimedica.com. 26 October 2020.
- ↑ "Top 10 Patient Monitoring Solution Companies - 2020". www.mdtechreview.com. December 21, 2020.
- ↑ Ford, Omar (7 May 2021). "Looking at the Major Trends in this Year's MDEA Program". mddionline.com.
- ↑ "MDEA | 2021 Winners". www.mdeawards.com.
- ↑ "WHO compendium of innovative health technologies for low-resource settings 2021. COVID-19 and other health priorities". www.who.int.
- ↑ Kiang, Tina; Courtney, Todd. "Re: K180902" (PDF). FDA.
- ↑ "Respiratory Device Reuse for Coronavirus". www.ocbj.com.
- ↑ 12.0 12.1 West, JB; Wang, DL; Prisk, GK; Fine, JM; Bellinghausen, A; Light, M; Crouch, DR (1 January 2019). "Noninvasive measurement of pulmonary gas exchange: comparison with data from arterial blood gases". American Journal of Physiology. Lung Cellular and Molecular Physiology. 316 (1): L114–L118. doi:10.1152/ajplung.00371.2018. PMC 6883287 Check
|pmc=value (help). PMID 30335497. - ↑ 13.0 13.1 Howe, CA; MacLeod, DB; Wainman, L; Oliver, SJ; Ainslie, PN (October 2020). "Validation of a Noninvasive Assessment of Pulmonary Gas Exchange During Exercise in Hypoxia". Chest. 158 (4): 1644–1650. doi:10.1016/j.chest.2020.04.017. PMID 32343965 Check
|pmid=value (help). - ↑ Pickerodt, PA; Kuebler, WM (1 May 2019). "Go West: translational physiology for noninvasive measurement of pulmonary gas exchange in patients with hypoxemic lung disease". American Journal of Physiology. Lung Cellular and Molecular Physiology. 316 (5): L701–L702. doi:10.1152/ajplung.00515.2018. PMID 30838868.
- ↑ West, JB; Crouch, DR; Fine, JM; Makadia, D; Wang, DL; Prisk, GK (August 2018). "A New, Noninvasive Method of Measuring Impaired Pulmonary Gas Exchange in Lung Disease: An Outpatient Study". Chest. 154 (2): 363–369. doi:10.1016/j.chest.2018.02.001. PMID 29452100. Unknown parameter
|s2cid=ignored (help) - ↑ West, JB; Wang, DL; Prisk, GK (1 April 2018). "Measurements of pulmonary gas exchange efficiency using expired gas and oximetry: results in normal subjects". American Journal of Physiology. Lung Cellular and Molecular Physiology. 314 (4): L686–L689. doi:10.1152/ajplung.00499.2017. PMID 29351442.
- ↑ West, John B. (2018). "A lifetime of pulmonary gas exchange". Physiological Reports. 6 (20): e13903. doi:10.14814/phy2.13903. PMC 6198137. PMID 30350350.
- ↑ West, John B.; Liu, Matthew A.; Stark, Phoebe C.; Prisk, G. Kim (1 August 2020). "Measuring the efficiency of pulmonary gas exchange using expired gas instead of arterial blood: comparing the "ideal" P o 2 of Riley with end-tidal P o 2". American Journal of Physiology. Lung Cellular and Molecular Physiology. 319 (2): L289–L293. doi:10.1152/ajplung.00150.2020. PMID 32491950 Check
|pmid=value (help). - ↑ Kelkar, KalpanaVinod (2015). "Post-operative pulmonary complications after non-cardiothoracic surgery". Indian Journal of Anaesthesia. 59 (9): 599–605. doi:10.4103/0019-5049.165857. PMC 4613407. PMID 26556919.
- ↑ Ivanov, Alexander; Yossef, James; Tailon, Jordan; Worku, Berhane M.; Gulkarov, Iosif; Tortolani, Anthony J.; Sacchi, Terrence J.; Briggs, William M.; Brener, Sorin J.; Weingarten, Jeremy A.; Heitner, John F. (April 2016). "Do pulmonary function tests improve risk stratification before cardiothoracic surgery?". The Journal of Thoracic and Cardiovascular Surgery. 151 (4): 1183–1189.e3. doi:10.1016/j.jtcvs.2015.10.102. PMID 26704058.
- ↑ Miskovic, A; Lumb, A.B. (March 2017). "Postoperative pulmonary complications". British Journal of Anaesthesia. 118 (3): 317–334. doi:10.1093/bja/aex002. PMID 28186222.
- ↑ Simmering, Jacob E.; Polgreen, Linnea A.; Comellas, Alejandro P.; Cavanaugh, Joseph E.; Polgreen, Philip M. (2016). "Identifying Patients With COPD at High Risk of Readmission". Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation. 3 (4): 729–738. doi:10.15326/jcopdf.3.4.2016.0136. PMC 5556956. PMID 28848899.
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